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Vagus Nerve Stimulation: Is the Evidence Convincing?

Vagus nerve stimulation (VNS) is certainly new—but is it effective? It took the FDA a long time to make up its mind, but eventually it approved the treatment in May 2005. (For more details on why the FDA flip-flopped on the issue, see “FDA Approval of VNS,” this issue.) In this article, we scrutinize the two pivotal studies leading to approval.

All editorial content is peer reviewed by the editorial board. Dr. Albucher, Dr. Balt, Dr. Gardiner, Dr. Goldberg, Dr. Lyman, Dr. Megna, Dr. Mick, Dr. Posternak, Dr. Spielmans, and Dr. Zuckerman have disclosed that they have no relevant financial or other interests in any commercial companies pertaining to this educational activity. Dr. Balt discloses that his spouse is employed as a sales representative for Otsuka America, Inc.

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